The purpose of this clinical study is to determine if there is an increased incidence and rate of aortic regurgitation in younger (</= 70 years of age) patients implanted with the Model 1000 and undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

Primary efficacy goal is to assess the regurgitation rates [ Time Frame: Six Years ] [ Designated as safety issue: Yes ]

Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.

Secondary Outcome Measures:

Hemodynamic functional data [ Time Frame: Six Years ] [ Designated as safety issue: No ]

Hemodynamic functional data

Safety Analysis will be based on the occurence of cardiovascular complications. [ Time Frame: Six Years ] [ Designated as safety issue: Yes ]

Safety Analysis will be based on one the occurence of cardiovascular complications. Events will be classified as device-related and non-device related.

A multi-center non-randomized trial designed to obtain 606 patient years. Each enrolled patient will be followed for a minimum of six (6) years. Preoperative, discharge or 30 days (whichever comes last), 3-6 month, and annual follow-up data are required.

Eligibility

Ages Eligible for Study:

up to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient is </= 70 years of age and requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction. (The three remaining valves must be of native tissue).

Patient is in satisfactory condition, based on the physical exam and Investigator's experience, to be an average or better operative risk, (i.e., likely to survive three years postoperatively).

Patient is geographically stable and willing to return to the implant center for follow-up visits.

Patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion Criteria:

Patient is older than seventy (70) years of age.

Patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 3 years.

Patient has a previously implanted prosthetic valve that is not being replaced by a study valve.

Patient requires mitral, tricuspid or pulmonic valve replacement.

Patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging.

Patient is participating in concomitant research studies of investigational products.

Patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116037